WO2016051901A1 - Ensemble de seringue, capuchon, et aiguille de ponction - Google Patents

Ensemble de seringue, capuchon, et aiguille de ponction Download PDF

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Publication number
WO2016051901A1
WO2016051901A1 PCT/JP2015/069602 JP2015069602W WO2016051901A1 WO 2016051901 A1 WO2016051901 A1 WO 2016051901A1 JP 2015069602 W JP2015069602 W JP 2015069602W WO 2016051901 A1 WO2016051901 A1 WO 2016051901A1
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WO
WIPO (PCT)
Prior art keywords
puncture needle
cap
outer cylinder
needle
tip
Prior art date
Application number
PCT/JP2015/069602
Other languages
English (en)
Japanese (ja)
Inventor
舩津加央里
阿部吉彦
飯淵るり子
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to EP15847565.7A priority Critical patent/EP3202446B1/fr
Priority to JP2016551594A priority patent/JP6782635B2/ja
Priority to AU2015326073A priority patent/AU2015326073B2/en
Publication of WO2016051901A1 publication Critical patent/WO2016051901A1/fr
Priority to US15/470,835 priority patent/US10369295B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A61M2005/311—Plugs, i.e. sealing rods or stylets closing the bore of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/343—Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub

Definitions

  • the present invention relates to a syringe assembly, a cap, and a puncture needle.
  • a cap is detachably attached to the tube tip of an outer cylinder provided with a puncture needle, thereby protecting the puncture needle and sealing the needle hole of the puncture needle. Stops to prevent leakage of chemicals.
  • the outer surface of the puncture needle is coated with a lubricant such as silicone oil for the purpose of reducing puncture resistance when injecting into the human body, etc., and reducing pain during puncture.
  • the cap described above When the cap described above is attached to the tube tip of the outer cylinder, the needle hole is sealed by the puncture needle being inserted into the cap. In this case, all or part of the lubricant coated on the outer surface of the puncture needle may be wiped off. As a result, the puncture resistance to the patient during use increases, and the patient feels pain. Increase.
  • the present invention has been made in view of such problems, and an object thereof is to provide an assembly for a syringe, a cap, and a puncture needle that can achieve both sufficiently low puncture resistance and sufficient sealing performance. .
  • the present invention provides a cylindrical outer cylinder main body having an opening at a base end, an outer cylinder having a cylindrical tip provided at a distal end of the outer cylinder main body, a blade surface and a needle.
  • a puncture needle that has a hole is held by the tube tip portion so as to protrude from the tube tip portion, and has a lubricant coating region on at least a part of the outer surface; and a needle hole that is detachably attached to the outer tube, And a cap for sealing the tip of the syringe, wherein the cap is provided adjacent to the accommodation hole for accommodating the puncture needle and the distal end side of the accommodation hole.
  • the length that the lubricant is wiped off from the outer surface of the puncture needle is preferably shortened.
  • the needle hole of the puncture needle can be sufficiently sealed. Therefore, according to this syringe assembly, it is possible to achieve both sufficiently low piercing resistance and sufficient sealing performance.
  • the length of the blade surface along the axial direction of the puncture needle may be 1 to 4 mm.
  • the length of the lubricant to be wiped from the outer surface of the puncture needle is limited to a range of 3 to 5 mm from the most distal end of the puncture needle, so that sufficiently small puncture resistance can be obtained more effectively. be able to.
  • the bottom wall preferably has a Shore D hardness of 35 to 55. With this configuration, sufficient sealing performance can be obtained more effectively.
  • the present invention includes a cylindrical outer cylinder main body having an opening at a base end, an outer cylinder having a cylinder tip provided at a distal end of the outer cylinder main body, a blade surface and a needle hole, A puncture needle that is held by the tube tip portion so as to protrude from the tube tip portion and has a lubricant coating region on at least a part of the outer surface, and is detachable from the outer tube of the assembly for a syringe, A cap for sealing the tip of the hole, the receiving hole for storing the puncture needle, the bottom wall portion provided adjacent to the tip end side of the receiving hole and capable of being pierced by the puncture needle, A stopper portion that regulates a puncture length of the puncture needle with respect to the bottom wall portion by contacting the outer cylinder, and when the cap is mounted on the outer cylinder, the cap and the puncture needle The length from the most proximal position of the contact area to the most proximal position of the blade surface is 1 to 3
  • the bottom wall portion preferably has a Shore D hardness of 35 to 55.
  • the present invention also provides a puncture needle having a blade surface and a needle hole, the first lubricant covering region formed on the outer surface, and the outer surface on the base end side of the first lubricant covering region.
  • a second lubricant-coated region formed adjacent to the second lubricant-coated region; and a lubricant-uncoated region formed adjacent to the outer surface on the base end side of the second lubricant-coated region,
  • One lubricant coating region has a thinner lubricant coating thickness than the second lubricant coating region, and is 1 to 5 in the proximal direction from the most proximal position of the blade surface from the most distal position of the puncture needle. It is formed over a range up to a position of 3 mm.
  • the lubricant coating thickness of the first lubricant coating region is thinner than that of the second lubricant coating region, the lubricant is applied along the axial direction of the puncture needle.
  • the amount of lubricant can be reduced as compared with the case of uniform coating.
  • the first lubricant-coated region has a lubricant coating thickness thinner than that of the second lubricant-coated region, the length of the first lubricant-coated region is moderately limited. Obtainable.
  • cap and puncture needle of the present invention both sufficiently low puncture resistance and sufficient sealability can be achieved.
  • FIG. 1 It is a schematic sectional drawing of the assembly for syringes concerning one Embodiment of this invention. It is an expanded sectional view of the cap of the assembly for syringes shown in FIG. 1, and its peripheral part. In the assembly for syringes shown in FIG. 1, it is an expanded sectional view which shows the state before a cap is mounted
  • FIG. 1 is a schematic cross-sectional view of a syringe assembly 10 according to an embodiment of the present invention.
  • the syringe assembly 10 includes an outer cylinder 12 in which an in-cylinder space 18 a is formed, a puncture needle 14 held at the distal end of the outer cylinder 12, and a cap 16 attached to the distal end of the outer cylinder 12.
  • the syringe assembly 10 is configured for a prefilled syringe. That is, a medicine is filled in the outer cylinder 12 (in-cylinder space 18a) of the syringe assembly 10, and a gasket is inserted into a predetermined position to constitute a prefilled syringe. Moreover, even if a pusher is attached to the gasket base end side as necessary, it may have a shape that allows the pusher to be attached.
  • the outer cylinder 12 is a transparent or translucent cylindrical body.
  • the constituent material of the outer cylinder 12 is preferably a material having low oxygen permeability and water vapor permeability, such as polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), Examples thereof include acrylic resins, acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate, various resins such as cyclic polyolefin, and glass. Of these, polypropylene and cyclic polyolefin are preferred from the viewpoint of application to autoclave sterilization.
  • the outer cylinder 12 has an outer cylinder main body 18 having an opening 19 at the proximal end and a cylinder tip 20 provided at the distal end of the outer cylinder main body 18.
  • the outer cylinder body 18 has an in-cylinder space 18a formed therein.
  • a flange portion 21 that surrounds the opening 19 and protrudes outward is provided at the base end of the outer cylinder main body 18.
  • the cylinder tip part 20 is formed with a smaller diameter than the outer cylinder main body 18 (part excluding the flange part 21).
  • the tube tip portion 20 is provided on the base end side of the annular head portion 22 having a substantially constant outer diameter along the axial direction, and on the base end side of the annular head portion 22.
  • a tapered portion 24 whose outer diameter increases in the direction.
  • a hole 26 penetrating in the axial direction is formed in the tube tip portion 20, and the puncture needle 14 is positioned by being fixed to the tube tip portion 20 while being inserted into the hole 26. Held by the unit 20.
  • Such fixation can also be formed by, for example, integrally forming the puncture needle 14 and the outer cylinder main body 18 by insert molding.
  • the puncture needle 14 is a linear hollow member, is held by the tube tip portion 20, and protrudes from the tube tip portion 20 in the distal direction.
  • the puncture needle 14 is formed with a needle hole 28 extending along the longitudinal direction thereof.
  • the needle hole 28 communicates with the in-cylinder space 18 a of the outer cylinder 12.
  • a blade surface 30 that is inclined with respect to the axis of the puncture needle 14 is formed at the tip of the puncture needle 14.
  • the tip (the most advanced part) of the blade surface 30 is the needle tip 15 of the puncture needle 14.
  • the puncture needle 14 is preferably made of a material having rigidity suitable for puncturing the patient's skin.
  • the constituent material of the puncture needle 14 include metals such as stainless steel, aluminum alloy, and titanium alloy, and hard resins such as polyphenylene sulfide.
  • the lubricant-coated region 32 exists over a range from the most distal portion (needle tip 15) of the puncture needle 14 to the vicinity of the distal end surface of the tube tip portion 20.
  • the lubricant 31 applied to the lubricant coating region 32 include liquid lubricants such as silicone oil.
  • the cap 16 has a bottomed cylindrical shape having an open end 34 at one end and a thick bottom wall 36 at the other end. As shown in FIG. 2, the puncture needle 14 is inserted into the bottom wall portion 36 with the cap 16 attached to the outer cylinder 12. In the case of the present embodiment, the entire cap 16 is made of an elastic body.
  • the constituent material of the cap 16 examples include rubbers such as isoprene rubber, butyl rubber, latex rubber, and silicone rubber, SBS elastomer, SEBS elastomer, and polyolefin elastomer.
  • the hardness of the constituent material of the cap 16 is preferably, for example, 35 to 55 in Shore D hardness.
  • the compression set (JIS K3262) of the constituent material of the cap 16 (particularly the bottom wall portion 36) is, for example, 10 to 24 from the viewpoint of improving the sealing performance and preventing liquid leakage from the needle tip 15. % Is preferred.
  • An accommodation hole 38 extending along the axial center of the cap 16 is formed inside the bottom wall portion 36 of the cap 16 and the side wall 39 extending from the bottom wall portion 36 toward the opening end portion 34.
  • the puncture needle 14 and the tube tip portion 20 can be inserted into the accommodation hole 38 from the opening end portion 34 toward the bottom wall portion 36 side.
  • the accommodation hole 38 is configured from portions having different inner diameters in the order of the small diameter portion 42, the medium diameter portion 44, and the large diameter portion 46 from the base end surface 40 of the bottom wall portion 36 toward the opening end portion 34. Has been.
  • the accommodation hole 38 includes an intermediate diameter portion 44 having an inner diameter smaller than the outer diameter of the annular head portion 22, a stopper portion 48 provided at the tip of the intermediate diameter portion 44, and a bottom from the stopper portion 48.
  • a small-diameter portion 42 formed toward the wall portion 36 and having an inner diameter smaller than the inner diameter of the medium-diameter portion 44, and a large-diameter portion 46 having an inner diameter larger than the outer diameter of the annular head portion 22. Yes.
  • the small diameter portion 42 is a portion where the inner diameter is the smallest in the accommodation hole 38, and the inner diameter of the small diameter portion 42 is larger than the outer diameter of the puncture needle 14. Therefore, the inner peripheral surface of the accommodation hole 38 (specifically, the inner peripheral surface of the small diameter portion 42) is not in contact with the outer surface of the puncture needle 14 and is covered with the outer surface of the puncture needle 14. It is not in contact with the lubricant 31.
  • the stopper portion 48 is a step based on the inner diameter difference between the small diameter portion 42 and the medium diameter portion 44.
  • the stopper portion 48 abuts the distal end surface of the tube tip portion 20 when the tube tip portion 20 is inserted into the accommodation hole 38, so that the puncture needle 14 is inserted into the final insertion position of the tube tip portion 20 and the bottom wall portion 36. Specifies the length of inclusion. That is, the stopper portion 48 restricts the tube tip portion 20 from entering the accommodation hole 38 beyond the final insertion position of the tube tip portion 20.
  • the final insertion position of the tube tip portion 20 and the puncture needle 14 with respect to the bottom wall portion 36 are brought into contact with the outer tube main body 18.
  • Another stopper portion that defines the stabbed length may be provided at the base end portion of the cap 16.
  • a temporary stopper portion 50 is formed between the medium diameter portion 44 and the large diameter portion 46.
  • the temporary stopper 50 temporarily stops the entry of the cylinder tip 20 into the accommodation hole 38. It has a function.
  • the temporary stopper 50 may not be provided.
  • the cap 16 is entirely made of an elastic body.
  • the cap 16 is made of a hard material (for example, hard resin, metal, etc.) that is detachably attached to the outer cylinder 12.
  • a wall portion A wall portion
  • the accommodation hole 38 may be a hole whose diameter decreases in a tapered shape toward the distal direction.
  • the cap 16 is detachably attached to the tube tip portion 20, but in yet another modified example of the cap 16, it is detachably attached to the distal end portion of the outer tube main body 18 instead of the tube tip portion 20. It may be configured as follows.
  • the length L 1 (from the most proximal end position of the contact area between the cap 16 and the puncture needle 14 to the most proximal end position of the blade surface 30 with the cap 16 attached to the outer cylinder 12.
  • the length of insertion L1 to the blade edge base end is also 1 to 3 mm.
  • the state in which the cap 16 is attached to the outer cylinder 12 means that the cap 16 is removed in a state in which the cylinder tip 20 is inserted into the accommodation hole 38 to a predetermined maximum insertion depth as shown in FIG. 2. It is attached to the cylinder 12.
  • the most proximal position of the contact area between the cap 16 and the puncture needle 14 is the bottom wall of the puncture needle 14. It coincides with the most proximal end position (the proximal end face 40 of the bottom wall portion 36) of the portion stabbed into the portion 36.
  • the length of the blade surface 30 (blade surface length) along the axial direction of the puncture needle 14 is preferably 1 to 4 mm, and more preferably 1 to 2 mm.
  • the length L2 (hereinafter referred to as the distance from the most proximal position of the contact region between the cap 16 and the puncture needle 14 to the most distal position (needle tip 15) of the puncture needle 14 , Also referred to as “sticking length L2 to the tip of the blade surface”) is preferably 2 to 7 mm, more preferably 3 to 5 mm in consideration of a normal blade surface length.
  • the cap 16 and the outer cylinder 12 are arranged so that the axis of the puncture needle 14 is along the axis a of the accommodation hole 38 and the tip of the puncture needle 14 faces the open end 34. Adjust the relative position. Then, the cap 16 and the outer cylinder 12 are relatively changed in the direction of approaching each other along the axis a, so that the puncture needle 14 and the cylinder tip portion 20 of the outer cylinder 12 are inserted into the accommodation hole 38. .
  • the puncture needle 14 and the tube tip portion 20 are inserted into the large-diameter portion 46 having a larger diameter before being inserted into the medium-diameter portion 44 and the small-diameter portion 42, and the tip surface of the annular head portion 22 is temporarily inserted. Abuts against the stopper portion 50. As a result, the insertion of the puncture needle 14 and the tube tip portion 20 is temporarily stopped (stopped at one end), and the axial center a of the accommodation hole 38 and the axial center of the puncture needle 14 can be made to substantially coincide with each other.
  • the annular head portion 22 gets over the temporary stopper portion 50 and enters the inside diameter portion 44.
  • the inner peripheral surface of the intermediate diameter portion 44 and the outer peripheral surface of the annular head portion 22 are in close contact with each other, an airtight seal is formed between the intermediate diameter portion 44 and the tube tip portion 20, and the tip of the puncture needle 14 Begins to be inserted into the bottom wall portion 36 from the base end face 40.
  • the puncture needle 14 As the puncture needle 14 is inserted into the bottom wall portion 36, a part of the lubricant 31 coated on the outer surface of the puncture needle 14 is wiped off by the base end surface 40 of the bottom wall portion 36. That is, the lubricant 31 is wiped off on the outer surface of the portion of the puncture needle 14 that is inserted into the bottom wall portion 36 (hereinafter referred to as “the insertion portion of the puncture needle 14”).
  • the lubricant 31 is not completely wiped off on the outer surface of the puncture portion of the puncture needle 14, but is present in a small thickness. This is schematically shown in FIG.
  • the puncture needle 14 portion protruding from the tube tip portion 20 is, in order from the distal end side to the proximal end side, a first lubricant coating region 32A (region indicated by a large number of dots), A second lubricant coating region 32B (a region indicated by cross-hatching) and a lubricant non-coating region 52 are provided.
  • the lubricant coating region 32 described above is configured by the first lubricant coating region 32A and the second lubricant coating region 32B.
  • the first lubricant coating region 32A is such that the lubricant 31 is wiped off when the puncture needle 14 is inserted into the bottom wall portion 36, so that the coating thickness of the lubricant 31 is the second lubricant coating region 32B. It is the place where it became thinner. That is, the puncture portion of the puncture needle 14 corresponds to the first lubricant coating region 32A. Accordingly, the first lubricant coating region 32A is formed over a range from the most distal position (needle tip 15) of the puncture needle 14 to a position of 1 to 3 mm in the proximal direction from the most proximal position of the blade surface 30. ing.
  • the length of the first lubricant coating region 32A is the same as the above-described insertion length L2 to the blade surface tip, preferably 2 to 7 mm, and more preferably 3 to 5 mm. preferable.
  • the lubricant coating thickness of the second lubricant coating region 32B is preferably 0.1 to 5 ⁇ m, for example. More preferably, it is 0.2 to 3 ⁇ m.
  • the length L3 of the second lubricant coating region 32B is preferably equal to or longer than the piercing length L1 to the blade surface base end, and is preferably 3 to 5 mm, for example.
  • the lubricant uncoated region 52 is a portion where the lubricant 31 is not originally coated.
  • the length L1 is 1 to 3 mm.
  • the puncture length L1 to the blade surface proximal end of the puncture needle 14 is 1 mm or more, the needle hole 28 of the puncture needle 14 can be sufficiently sealed.
  • the lubricant 31 wipes from the outer surface of the puncture needle 14 when the puncture needle 14 is inserted into the bottom wall portion 36. The length taken can be shortened. As a result, an increase in piercing resistance can be suppressed as much as possible. That is, a sufficiently small piercing resistance can be obtained.
  • unvulcanized rubber compounds A to H as cap materials were prepared.
  • This unvulcanized rubber compound is made into a cap by crosslinking by pressurizing and heating using a predetermined molding die, and for each of the obtained samples, compression set (conforming to JIS K6262) and Hardness (Shore D) was evaluated.
  • a 27G (gauge) (blade surface length 2.0 mm) puncture needle was used to create an outer cylinder with a needle to which the cap described above can be attached. Then, after applying a lubricant (silicone oil; viscosity: 12500 cst) to the tip of the puncture needle, attach the caps A to H described above to create a syringe assembly with the needle tip of the puncture needle inserted into the cap. did.
  • a 29G puncture needle was prepared, and a C cap (Shore D hardness: 45) was prepared and compared.
  • the piercing length to the blade surface base end and the piercing length to the blade surface tip when the cap was attached were 0.5 to 4.0 mm and 2.5 to 6.0 mm, respectively, as shown in the separate table. And the assembly for syringes sterilized was produced by autoclaving them.
  • the puncture resistance (maximum puncture resistance and trunk resistance) of the sterilized syringe assembly produced as described above was measured. Specifically, the cap was removed and an autograph (AGS-H, manufactured by Shimadzu Corporation) was used, and 50 mm / min. Each puncture needle is punctured into silicone rubber (thickness 0.5 mm) at a speed of 5 mm and the maximum resistance value (maximum puncture resistance) from the needle tip to 5 mm piercing and the maximum resistance value after passing 5 mm from the needle tip (Body resistance) was measured.
  • the upper row shows the evaluation of the piercing resistance test (good / good), and the maximum piercing resistance (good if less than 0.2N) is shown on the left side.
  • the body resistance (less than 0.06 N is good) is shown on the right side.
  • the lower row shows the pass / fail determination (OK / NG) of the sealability test, the determination result at 200 kPa on the left side, and the determination result at 400 kPa on the right side.
  • the sample with a piercing length to the blade surface proximal end of 0.5 mm does not provide sufficient sealing performance, and the blade surface It was found that in the sample having a piercing length to the base end of 4 mm (the piercing length to the tip of the blade surface was 6 mm), the piercing resistance was too large when compared with the same hardness.
  • the sealing performance was determined to be NG at 400 kPa, but 200 kPa.
  • the length from the most proximal end position of the contact region between the cap 16 and the puncture needle 14 to the most distal position of the puncture needle 14 is 3 when the cap 16 is attached to the outer cylinder 12. ⁇ 5 mm.
  • the length of the lubricant 31 that can be wiped off from the outer surface of the puncture needle 14 is limited to a range of 3 to 5 mm from the most distal position of the puncture needle 14 at the longest. Can get to.
  • the length of the blade surface 30 along the axial direction of the puncture needle 14 is 1 to 4 mm, a sufficiently small puncture resistance can be obtained with certainty.
  • the syringe assembly 10, the cap 16, and the puncture needle 14 are configured for a prefilled syringe.
  • the application target of the present invention is not limited to the prefilled syringe, and is applicable to other types of syringes. Of course you can.
  • the puncture needle 14 includes the first lubricant coating region 32A formed on the outer surface, and the proximal end side of the first lubricant coating region 32A.
  • a second lubricant-coated region 32B formed adjacent to the outer surface of the first lubricant, and a lubricant-uncoated region 52 formed adjacent to the outer surface on the proximal side of the second lubricant-coated region 32B.
  • the first lubricant coating region 32A has a thinner lubricant coating thickness than the second lubricant coating region 32B, and is based on the most proximal end position of the blade surface 30 from the most distal position of the puncture needle 14.
  • Such a puncture needle 14 may be applied to a configuration in which a cap 54 that covers the puncture needle 14 in a non-contact state with respect to the puncture needle 14 is detachably attached to the outer cylinder 12 as shown in FIG. .
  • the lubricant coating thickness of the first lubricant coating region 32A is thinner than the second lubricant coating region 32B, so that the lubricant 31 is uniformly coated along the axial direction of the puncture needle 14.
  • the amount of the lubricant 31 can be reduced as compared with the case.
  • the first lubricant coating region 32A has a thinner lubricant coating thickness than the second lubricant coating region 32B, the length is moderately limited, so that the sufficiently small piercing is performed. Resistance can be obtained.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
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  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un ensemble de seringue (10) qui est pourvu des éléments suivants : un cylindre externe (12) ayant une pointe de cylindre (20) ; une aiguille de ponction (14) qui fait saillie à partir de la pointe de cylindre (20) ; et un capuchon (16) qui scelle l'extrémité d'un trou d'aiguille (28), le capuchon étant raccordé de façon détachable au cylindre externe (12). Le capuchon (16) a une ouverture de stockage (38) qui stocke l'aiguille de ponction (14), une paroi inférieure (36) dans laquelle l'aiguille de ponction (14) pénètre, et une butée (48) qui définit la profondeur à laquelle l'aiguille de ponction (14) pénètre dans la paroi inférieure (36). Le capuchon (16) étant fixé au cylindre externe (12), une longueur (L1) mesurée à partir de la position d'extrémité de base la plus éloignée de la région de contact entre le capuchon (16) et l'aiguille de ponction (14), à la position d'extrémité de base la plus éloignée d'une face de bord (30), est de 1 à 3 mm.
PCT/JP2015/069602 2014-10-01 2015-07-08 Ensemble de seringue, capuchon, et aiguille de ponction WO2016051901A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP15847565.7A EP3202446B1 (fr) 2014-10-01 2015-07-08 Ensemble de seringue, capuchon, et aiguille de ponction
JP2016551594A JP6782635B2 (ja) 2014-10-01 2015-07-08 シリンジ用組立体
AU2015326073A AU2015326073B2 (en) 2014-10-01 2015-07-08 Syringe assembly, cap, and puncture needle
US15/470,835 US10369295B2 (en) 2014-10-01 2017-03-27 Syringe assembly, cap, and puncture needle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014-203388 2014-10-01
JP2014203388 2014-10-01

Related Child Applications (1)

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US15/470,835 Continuation US10369295B2 (en) 2014-10-01 2017-03-27 Syringe assembly, cap, and puncture needle

Publications (1)

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WO2016051901A1 true WO2016051901A1 (fr) 2016-04-07

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EP (1) EP3202446B1 (fr)
JP (1) JP6782635B2 (fr)
AU (1) AU2015326073B2 (fr)
WO (1) WO2016051901A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109789279A (zh) * 2016-09-30 2019-05-21 泰尔茂株式会社 盖、注射器组装体及预灌封注射器
EP3520845A4 (fr) * 2016-09-28 2020-06-24 Terumo Kabushiki Kaisha Ensemble seringue, seringue pré-remplie, capuchon d'étanchéité pour corps de seringue avec aiguille de ponction, et emballage d'ensemble seringue

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3777931A4 (fr) * 2018-03-28 2021-12-22 CMC-Pharma Co., Ltd Kit seringue de mélange de deux composants pré-rempli

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JPH03173576A (ja) * 1989-11-22 1991-07-26 Becton Dickinson & Co 皮下注射器組立体
JPH10305098A (ja) * 1997-04-23 1998-11-17 Carl Zeiss:Fa 使い捨て注射器用のニードルキャップ装置
US20020062108A1 (en) * 2000-11-17 2002-05-23 Serge Courteix Protection device for syringe needle
JP2004532060A (ja) * 2001-03-15 2004-10-21 ベクトン・ディキンソン・アンド・カンパニー シリンジおよびニードルシールド組立品および該組立品を滅菌する方法
JP2013519415A (ja) * 2010-02-11 2013-05-30 リバーシッジ、バリー・ピーター 医療用針カバー装置

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JPS54135485A (en) * 1978-04-12 1979-10-20 Teijin Ltd Medical stylus protector
JPS592343U (ja) * 1982-06-26 1984-01-09 株式会社トツプ 予め薬液を充填した注射筒
JPH0360960U (fr) * 1989-10-19 1991-06-14
US20130012886A1 (en) * 2010-03-18 2013-01-10 Daikyo Seiko, Ltd. Syringe needle cap

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Publication number Priority date Publication date Assignee Title
JPH03173576A (ja) * 1989-11-22 1991-07-26 Becton Dickinson & Co 皮下注射器組立体
JPH10305098A (ja) * 1997-04-23 1998-11-17 Carl Zeiss:Fa 使い捨て注射器用のニードルキャップ装置
US20020062108A1 (en) * 2000-11-17 2002-05-23 Serge Courteix Protection device for syringe needle
JP2004532060A (ja) * 2001-03-15 2004-10-21 ベクトン・ディキンソン・アンド・カンパニー シリンジおよびニードルシールド組立品および該組立品を滅菌する方法
JP2013519415A (ja) * 2010-02-11 2013-05-30 リバーシッジ、バリー・ピーター 医療用針カバー装置

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Title
See also references of EP3202446A4 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3520845A4 (fr) * 2016-09-28 2020-06-24 Terumo Kabushiki Kaisha Ensemble seringue, seringue pré-remplie, capuchon d'étanchéité pour corps de seringue avec aiguille de ponction, et emballage d'ensemble seringue
CN109789279A (zh) * 2016-09-30 2019-05-21 泰尔茂株式会社 盖、注射器组装体及预灌封注射器
CN109789279B (zh) * 2016-09-30 2021-09-17 泰尔茂株式会社 盖、注射器组装体及预灌封注射器

Also Published As

Publication number Publication date
JPWO2016051901A1 (ja) 2017-07-13
EP3202446B1 (fr) 2022-01-12
EP3202446A1 (fr) 2017-08-09
JP6782635B2 (ja) 2020-11-11
US20170197040A1 (en) 2017-07-13
AU2015326073A1 (en) 2017-04-13
US10369295B2 (en) 2019-08-06
AU2015326073B2 (en) 2019-11-14
EP3202446A4 (fr) 2018-06-13

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